WO2003002197A1

WO2003002197A1 - A stylet unit

Info

Publication number: WO2003002197A1
Application number: PCT/SE2002/000707
Authority: WO
Inventors: Per Jarl; Rolf Hill; Bengt-Åke NORÉN
Original assignee: St. Jude Medical Ab
Priority date: 2001-06-29
Filing date: 2002-04-09
Publication date: 2003-01-09
Also published as: EP1404408B1; SE0102353D0; DE60212843T2; US7201724B2; EP1404408A1; DE60212843D1; US20040243209A1

Abstract

A stylet unit, comprising a flexible, tubular stylet sleeve (1), a flexible innet stylet wire (2), inserted into the stylet sleeve (1), at least one portion of said stylet wire (2) and at least one portion of a channel defined by the stylet sleeve (1) having a non-circular cross-section for preventing rotation of the wire (2) inside the sleeve (1), a handle (3), by means of which the sleeve (1) and the stylet wire (2) are movable in relation to each other in a longitudinal direction, the sleeve (1) and the wire (2) being connected at one end thereof to the handle (3). The sleeve (1) is rotationally arranged within the handle (3).

Description

A stylet unit

TECHNICAL FIELD

The present invention relates to a stylet unit, comprising a flexible, tubular stylet sleeve, and a flexible inner stylet wire, inserted into the stylet sleeve. At least one portion of said stylet wire and at least one portion of a channel defined by the stylet sleeve has a non-circular cross-section for preventing rotation of the wire inside the sleeve. The stylet unit also comprises a handle, by means of which the sleeve and the stylet are movable in relation to each other in a longitudinal direction, the sleeve and the wire being connected at one end thereof to the handle.

Stylet units of the above type are widely used as a means for medical purposes. The wire and the sleeve are adapted to be inserted into an oblong element, normally an electrode cable of a heart stimulator that is to be introduced into a mammal body for surgical purposes. The purpose of the unit is to locate the oblong element in the body. Typically, an end of the cable is anchored in the atrium or ventricle of a patient by means of the stylet unit.

DESCRIPTION OF PRIOR ART

A stylet unit of the above general type is especially suitable for stiffening and maneuvering a hollow electrode cable for a heart stimulator, in conjunction with introduction of the electrode cable into a patient's heart, and for anchoring the contact electrode (electrode head) on the distal end of the cable in a cavity in the heart. Introduction of such an element into the heart is usually performed through a suitable vein, and the contact electrode can be anchored in the right ventricle or atrium. The stylet unit temporarily contained inside the hollow electrode cable extends through the cable's central channel from the cables proximal end (which is subsequently connected to the heart stimulator) to its distal end on which the contact electrode is located.

Especially in the anchoring of a contact electrode in the heart's atrium, a stylet unit is appropriately used with which the distal end section of the electrode cable can be given a suitable shape, simplifying the introduction of the end section into the atrial auricle and anchoring of the contact electrode in the trabeculae of the atrial auricle. After the contact electrode (that is the electrode cable) has been anchored at the desired site in the heart, the stylet unit is withdrawn from the electrode cable.

U.S. Patent no. 5,728,148 describes and shows a stylet unit with a double stylet combination consisting of a flexible, tubular stylet sleeve holding an inner stylet wire which is moveable in the sleeve's central channel. At the proximal end of this known stylet unit, there is an operating handle with which the sleeve and inner stylet wire can be moved in relation to each other to retract the wire's pre-bent distal end section into the distal end section of the surrounding sleeve, or to deploy the pre-bent distal end section outside the opening of the sleeve's end section into the central channel of the distal end section of the surrounding electrode cable, thereby imparting the desired bent shape to the end of the cable. Accordingly, a J-shaped distal end of the electrode cable, suitable for anchoring purposes, can be obtained by deploying the distal end section of the pre-bent wire into the electrode channel.

In order to prevent undesirable rotation of the stylet wire in the surrounding sleeve within at least a longitudinal section of the stylet unit, the wire and the sleeve channel present corresponding non- circular cross sections along at least a longitudinal section of the stylet. Normally, the non-circular sections are located at the respective distal end of the wire and sleeve. Both the wire and the sleeve is non-rotationally arranged within the handle, in order to permit the maneuvring of the distal end portion of the wire and sleeve.

However, when the handle is turned, for example in order to locate the thus J-shaped (or similarly shaped) and implanted electrode cable end for the exact positioning thereof, the stylet sleeve produces a torsional moment on the end of the wire. This is due to the non- circular sections of the wire and the sleeve still being in engagement with each other in the distal end regions thereof. The torsional moment on the wire might result in the wire being broken or damaged. It might thus happen that a broken end of the wire is left in the electrode cable. Such a broken end may cause a major failure on the implantable lead system, with a detrimental result for the patient.

BRIEF DESCRIPTION OF THE INVENTION

It is an object of the invention to present a stylet unit of the type initially defined in which any torsional moment applied to the stylet wire due to the turning of the handle does not cause damage or breakage on the wire.

Accordingly, it is an object of the invention to present a stylet unit that can be turned one or more turns without running the risk of thereby damaging the stylet wire due to any torsional moment thereby being applied to the wire via the surrounding sleeve.

It is a further object of the invention to prevent a pre-bent stylet wire from being subjected to a damaging torsional moment from the surrounding stylet sleeve while being in a deployed state inside a human being into which an oblong element is located by means of the stylet unit.

The object of the invention is obtained by means of the initially defined stylet unit, characterised in that the sleeve is rotationally arranged within the handle. When the handle is turned, the sleeve will be free to rotate inside the handle. Accordingly, the sleeve is in an engagement with the handle that permits the operation of the sleeve in a longitudinal direction but leaves the sleeve free to rotate inside the handle. The term "rotationally ", as used herein, means rotation around the longitudinal axis of the sleeve.

The stylet wire is non-rotationally fixed to at least a part of the handle. This will be an essential pre-condition for making it possible to maneuvre the stylet distal end by turning at least said part of the handle.

Preferably, the handle comprises a handling element in engagement with the stylet sleeve and movable in a longitudinal direction in relation to the stylet wire, the stylet sleeve being rotationally arranged in relation to the handling element. Thereby, the handling element itself need not be rotationally arranged in relation to the rest of the handle in order to achieve the rotational arrangement of the sleeve.

According to a preferred embodiment the stylet sleeve is fastened to a rigid tube, which is in engagement with the handling element, said tube being rotationally arranged in relation to the handling element. The arrangement of the tube is advantageous from several point of views. Above all it forms a reasonably large body in relation to which the handling element may be rotationally arranged. It would be difficult to position the thin and flexible sleeve directly in a reliable rotational engagement with the surrounding handling element. It should be understood that the word "tube" as used herein does not imply that the tube must have any specific length in the longitudinal direction. Its main purpose is to act as a securing point for the sleeve. However, it may also act as a cover for the wire in case the wire runs through the tube to the part of the handle to which it is secured.

Preferably, the tube comprises at least one recess for engagement with a corresponding projection of the handling element (or of any intermediate element between the handling element and the tube). Alternatively, or as a complement, the tube comprises at least one projection for engagement with a corresponding recess of the handling element (or of any intermediate element between the handling element and the tube).

According to the invention, a portion of the wire is pre-bent, said portion being located at an end thereof opposite to the end thereof fastened to the handle. That is, the distal end of the wire is pre-bent. The distal end of the sleeve should be pre-bent in an opposite direction in order to guarantee the straightness of the distal end of the stylet unit when the wire is in a retracted state in the sleeve. The wire and the sleeve channel preferably present non-circular cross sections at their distal ends.

The wire and the sleeve are adapted to be inserted into an oblong element that is to be introduced into a mammal body for surgical purposes, in order to locate the oblong element in the body. The oblong element may be an electrode cable for a heart stimulator, a coronary catheter or any other kind of hollow, oblong instrument. Further features and advantageous of the present invention are presented in the following, detailed description and in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following, embodiments of the invention will be described by way of example, with reference to the accompanying drawings, on which:

Fig. 1 is a schematic cross-sectional view of a part of a stylet unit according to the invention,

Fig. 2 is a schematic cross-sectional view of a detail of the stylet unit shown in fig. 1,

Fig. 3 is a cross sectional view of the detail shown in fig. 2 in an enlarged scale,

Fig. 4 is cross sectional view of an alternative embodiment of the detail shown in fig. 3, and

Fig. 5a-5e are views showing different cross sections of a section of non-circular stylet wire and stylet sleeve

DETAILED DESCRIPTION OF THE INVENTION

Fig. 1 shows a first embodiment of the inventive stylet unit. The stylet unit is especially suitable for stiffening and maneuvering a hollow electrode cable for a heart stimulator (not shown), in conjunction with introduction of the electrode cable into a patient's heart, and for anchoring the contact electrode (electrode head) on the distal end of the cable in a cavity in the heart. Introduction of such an element into the heart is usually performed through a suitable vein, and the contact electrode can be anchored in the right ventricle or atrium. The stylet unit temporarily contained inside the hollow electrode cable extends through the cable's central channel from the cables proximal end (which is subsequently connected to the heart stimulator) to its distal end on which the contact electrode is located.

The stylet unit comprises a flexible, tubular stylet sleeve 1, and a flexible inner stylet wire 2, inserted into the stylet sleeve 1 and arranged to move freely in a longitudinal direction inside the sleeve 1. Both the sleeve 1 and the wire 2 is preferably made of a metal such as steel. The sleeve 1 and the wire 2 has a proximal end and a distal end. In the area preceding its distal end, the inner stylet wire 2 has a pre-bent distal end section. Preferably, the sleeve 1 has a corresponding pre-bent distal end section. The sleeve 1 and the wire 2 are pre-bent in opposite directions and the pre-tensioning forces thereof act in the same plane and are adapted such that the prebends of the sleeve 1 and the wire 2 cancel each other when the wire 2 is retracted into the sleeve 1. This requires the wire 2 to be kept from rotating in the sleeve 1.

The sleeve 1 and inner stylet wire 2 can be moved in relation to each other to retract the wire's 2 pre-bent distal end section into the distal end section of the surrounding sleeve 1, or to deploy the pre-bent distal end section outside the opening of the sleeve's 1 end section into the central channel of the distal end section of the surrounding electrode cable, thereby imparting the desired bent shape to the end of the cable. Accordingly, a J-shaped distal end of the electrode cable, suitable for anchoring purposes, can be obtained by deploying the distal end section of the pre-bent wire 2 into the electrode channel. Sleeve 1 and wire 2 are introduced into the electrode cable, or similar oblong element to be implanted, in order to stiffen the latter and enable it to be guided through and be located in the patient. After the location having been completed the stylet unit is retracted out of the electrode or the like via the proximal end thereof.

At least one portion of said stylet wire 2 and at least one portion of a channel defined by the stylet sleeve 1 has a non-circular cross- section for preventing undesirable rotation of the wire 2 inside the sleeve 1. The non-circular cross section of the sleeve 1 and the wire 2 is shown in detail in fig. 5. The non-circular sections of the wire 2 and the sleeve 1 are preferably located at or near the distal ends thereof, and have lengths of approximately 5-10 cm. However, other positions and lengths of interacting, non-circular cross sections of the wire 2 and the sleeve 1 are possible.

The stylet unit also comprises a handle 3, by means of which the sleeve 1 and the stylet wire 2 are movable in relation to each other in a longitudinal direction, the sleeve 1 and the wire 2 being connected at one end thereof, the proximal end, to the handle 3.

The handle 3 comprises a handling element 4, a handle part 5 and a guide element 6 along which the handling element 4 is movable towards and from said part 5 of the handle. Handling element 4, handle part 5 and guide element 6 are preferably made of a polymer material.

The handling element 4 is generally ring-shaped and comprises a channel or central opening through which the wire 2 extends to the handle part 5. It also comprises guiding recesses via which it is in engagement with the guide element 6. The handling element 4 is non- rotationally arranged in relation to the guide element 6. It is intended that the handling element 4 be gripped outwardly by an operator for the moving thereof in relation to the handle part 5 and guide element 6.

The handling element 4 is indirectly connected to the sleeve 1 via a tube 7 and an intermediate element 8 and is used for moving the sleeve 1 in a longitudinal direction in relation to the wire 2. The sleeve 1 is fastened to the tube 7. The tube 7, preferably made of a metal such as steel, is rotationally arranged in relation to the handling element 4. By manually moving the handling element 4 towards the handle part 5, to which the wire is connected, the distal end of the wire 2 is deployed from the distal end of the sleeve 1.

The intermediate element 8 comprises a bracket, for example ring- shaped with an inner diameter corresponding to the outer diameter of the tube 7. According to a first embodiment, shown in fig. 3, the intermediate element 8 is rotationally arranged in relation to the tube 7. Preferably it is made of metal or the same material as the tube 7. On the tube 7 there are provided projections 9 on each side of the intermediate element 8, in engagement with and locking the intermediate element in the longitudinal direction in relation to the tube 7. The projections 9 could be any projection attached to the tube 7 either as an integrated part of the tube 7 or as a separate part, such as a cylindrical ring, attached to the tube 7 by means of welding, brazing, gluing etc. The outer periphery of the intermediate element 8 comprises a recess 10 into which a corresponding projection of the handling element 4 is to be inserted. The recess 10 is, but need not be, adapted to permit rotation of the handling element 4 in relation to the intermediate element 8, since rotation between the sleeve 1 and the handling element is provided by the connection between the tube 7 and the intermediate element 8. In other words, the intermediate need not be rotationally arranged in relation to the handling element 4 for achieving the inventive purpose, but may be so in order to, for example, provide for a rotational relationship even in case the tube 7 would accidentally stick to the intermediate part 8.

As an alternative to the projections 9, the tube could be provided with a recess with which a corresponding projection on the intermediate element 8 could be in engagement in order to provide for the fixing of the tube 7 in relation to the intermediate element 8 in the longitudinal direction of the sleeve 1 and wire 2.

According to a second embodiment, shown in fig. 4, the intermediate element 8 is non-rotationally arranged in relation to the tube 7. The tube 7 is preferably made of the same material as the intermediate element 8 and could be attached to the later by a weld joint, braze joint, glue joint etc..

It should be emphasised that a number of alternative embodiments will be obvious for a man skilled in the art concerning how to achieve the rotational arrangement of the sleeve in relation to the handling element 4, and that such embodiments are within the scope of the invention. Accordingly, by tube 7 is meant any element presenting a through hole for the passage of the wire 2. The intermediate part 8 is preferred, but may as well be omitted as long as there is a provided any engagement means between the handling element 4 and the tube 7. Such engagement means could include stop rings or any other procjetion arranged on any one of the tube 7 and the handling element 4, inhibiting longitudinal movement of the handling element 4 in relation to the tube 7 but permitting rotation of the tube 7 in relation to the handling element 4. The invention also covers embodiments (not shown) in which the sleeve 1 is rotationally fastened to a tube corresponding to the tube 7 or to a handling element corresponding to the handling element 4. Corresponding engagement means, inhibiting mutual longitudinal movement and permitting mutual rotation, should then be provided on the sleeve 1 and/ or the part to which it is fastened.

The handle part 5 may be a separate part or an integrated part of the guide element 6. Here, the handle part 5 is fastened to the guide element 6 by means of a thread joint at the end of the guide element 6. For this purpose the handle part 5 comprises a recess having an inner threading (not shown in detail). This means that at least temporarily, during use of the stylet unit, said part 5 of the handle 3 is non-rotationally arranged in relation to the guide element 6 and in relation to the handling element 4. The proximal end of the wire 2 is fastened to the bottom of the handle part 5. Preferably, a tube 11, preferably made of metal, for covering and guiding the wire 2 is fastened to or integrated with the handle part 5. For this purpose the inner diameter of the tube 11 is only slightly larger than the diameter of the wire 2. The tube 7 to which the sleeve 1 is fastened is telescopically arranged in relation to the cover and guide tube 11 such that the first tube 7 is inserted into the latter tube 11 when the handling element 4 is moved towards the handle part 5. The length of the respective tube 7, 11 is adapted such that they overlap each other in all positions of the handling element 4 in relation to the handle part 5. Thereby, the proximal end part of the wire 2 not covered by the sleeve is constantly covered by said tubes 7, 11.

It is intended that the handle part 5 be gripped by an operator and that, by rotating it, the position of the distal end of the wire 2 inside the patient can be adjusted. The rotational arrangement of the sleeve 1 in the handle 3 prevents the sleeve from implying unwanted torsional moment on the wire 2 upon turning or rotation of the handle 3 while the distal end of the wire 2 is deployed from the distal end of the sleeve 1.

Figs. 5a-5e show different types of non-circular cross-sections of the sleeve 1 and the wire 2. The gap or spacing 12 between the outer periphery of the wire 2 and the inner periphery of the sleeve 1 is adapted to enable smooth mutual movement in the longitudinal direction but small enough to prevent rotation of the wire 2 inside the sleeve 1.

It should be noted that the above embodiments only have been disclosed by way of example, and that the invention is not restricted to those embodiments. A plurality of alternative embodiments will be obvious for a man skilled in the art without thereby going beyond the scope of the invention as claimed in the appended claims, supported by the description and the accompanying drawings.

Claims

PATENT CLAIMS

1. A stylet unit, comprising

- a flexible, tubular stylet sleeve (1) - a flexible inner stylet wire (2), inserted into the stylet sleeve (1), at least one portion of said stylet wire (2) and at least one portion of a channel defined by the stylet sleeve (1) having a non-circular cross- section for preventing rotation of the wire (2) inside the sleeve (1),

- a handle (3), by means of which the sleeve (1) and the stylet wire (2) are movable in relation to each other in a longitudinal direction, the sleeve (1) and the wire (2) being connected at one end thereof to the handle (3), characterised in that,

- the sleeve (1) is rotationally arranged within the handle (3).

2. A stylet unit according to claim 1, characterised in that the stylet wire (2) is non-rotationally fixed to at least a part (5) of the handle (3).

3. A stylet unit according to claim 1 or 2, characterised in that the handle (3) comprises a handling element (4) in engagement with the stylet sleeve (1) and movable in a longitudinal direction in relation to the stylet wire (2), the stylet sleeve (1) being rotationally arranged in relation to the handling element (4).

4. A stylet unit according to claim 3, characterised in that the stylet sleeve (1) is fastened to a rigid tube (7), which is in engagement with the handling element (4), said tube (7) being rotationally arranged in relation to the handling element (4).

5. A stylet unit according to claim 4, characterised in that the tube (7) comprises at least one recess for engagement with a corresponding projection of the handling element (4) or of any intermediate element (8) located between the handling element (4) and the tube (7).

6. A stylet unit according to claim 4 or 5, characterised in that the tube (7) comprises at least one projection for engagement with a corresponding recess of the handling element (4) or of any intermediate element (8) located between the handling element (4) and the tube (7).

7. A stylet unit according to claim 4, characterised in that it comprises an intermediate element (8) located between the handling element (4) and the tube (7) and in engagement with the tube (7) and with the handling element (4), the intermediate element (8) being rotationally arranged in relation to the handling element (4) and/ or to the tube (7).

8. A stylet unit according to claim 7, characterised in that the intermediate element (8) comprises a bracket that is rotationally arranged around the tube (7) and non-rotationally arranged in relation to the handling element (4).

9. A stylet unit according to any one of claims 2-8, characterised in that it comprises a guide element (6) along which the handling element (4) is movable towards and from said part (5) of the handle.

10. A stylet unit according to claim 9, characterised in that the handling element (4) is non-rotationally arranged in relation to the guide element (6).

11. A stylet unit according to claim 9 or 10, characterised in that, at least temporarily, during use of the stylet unit, said part (5) of the handle is non-rotationally arranged in relation to the guide element (6) and in relation to the handling element (4).

12. A stylet unit according to any one of claims 1-11, characterised in that the non-circular portions of the sleeve (1) channel and the wire (2) are located at an end opposite to an end thereof fastened to the handle.

13. A stylet unit according to any one of claims 1-12, characterised in that a portion of the wire (2) is pre-bent, said portion being located at an end thereof opposite to the end thereof fastened to the handle.

14. A stylet unit according to any one of claims 1-13, characterised in that the wire (2) and the sleeve (1) are adapted to be inserted into an oblong element that is to be introduced into a mammal body for surgical purposes, in order to locate the oblong element in the body.